Neurology News Network for the week ending November 23, 2019.
This week's Neurology News Network covered a clinical trial on an ubrogepant, an investigational therapy developed for acute migraine treatment, as well as a new anti-epileptic therapy that has produced significant reductions in focal-onset seizures; Valbenazine proved effective in reducing involuntary movements in patients with tardive dyskinesia.
Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.
Analysis of the ACHIEVE II clinical trial suggests that ubrogepant, an investigational therapy developed by Allergan for acute migraine treatment, may be able to provide pain freedom and freedom of the most bothersome symptoms for adults with migraine. Compared to placebo, treatment with the oral calcitonin gene-related peptide antagonist resulted in significant rates of pain freedom at 2 hours for both doses assessed as well as significant rates of freedom from the most bothersome symptom with the higher dose. In March, the FDA accepted a new drug application for the Allergan agent, with supporting data coming from this study as well as its predecessor, ACHIEVE I, and 2 additional safety studies. The review period was set at 10 months, with a Prescription Drug User Fee Act action date in the fourth quarter of this year.
Cenobamate, an investigational anti-epileptic therapy that acts as a sodium channel antagonist, has proved positive in a new clinical trial, with results suggesting that the SK Life Science agent can produce significant reductions in focal-onset seizures with adjunctive therapy. The effect was observed in a dose-related fashion in the maintenance phase of the study which included 437 patients, with cenobamate being assessed in doses of 100, 200, and 400 mg, all of which resulted in significant reductions in median seizure frequency. Additionally, responder rates during the maintenance phase of the study were significantly higher for all doses of cenobamate.
Long-term results of a phase 3 study of valbenazine show that approximately 90% of patients with tardive dyskinesia reported a reduction of involuntary movements by 50% or more over a 48-week stretch. The open-label KINECT 4 trial included 163 patients who received a daily dose of valbenazine 40 mg, with escalation to 80 mg/d at week 4 based on efficacy and tolerability. Among the group of patients, 95.9% and 89.2% reported being much improved or very much improved on the Clinical Global Impression of Change-TD and Patient Global Impressive of Change rating scales, respectively.
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